3 Key Takeaways Of Annex 1: What It Means For Your Cold Chain Management

The latest update to Annex 1 clarifies and expands upon EMA guidelines for the manufacture of sterile medicinal products. Given that regulatory and manufacturing environments have changed dramatically since the last revision in 2007, the new guidelines are much needed and largely welcomed within the pharmaceutical industry.

Harmful contamination can occur at virtually any stage of drug product processing, storage, and transport. Consequently, the updated guidelines emphasize that manufacturers must integrate an effective risk management system into all aspects of the bulk drug product lifecycle.

What are the practical implications of all this, specifically for cold chain management? Sartorius asked a few in-house experts for their thoughts on the subject.